A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943

Obesity Clinical Trial

Official title:

A Randomized, Double-Blind, Phase 1 Study to Investigate the Effect of LY3437943 Versus Placebo on Calorie Intake and Energy Expenditure in Participants With Obesity Under Calorie Restriction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06313528
• Other study ID #: 18726
• Secondary ID: J1I-MC-GZBW
• Status: Recruiting
• Phase: Phase 1
• Start date: March 20, 2024
• Est. completion date: July 2025

Study information

• Verified date: April 2024
• Source: Eli Lilly and Company
• Contact: There may be multiple sites in this clinical trial. 1-877-CTLILL
• Phone: 1-317-615-4559
• Email: ClinicalTrials.gov[@]lilly.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of the study is to look at the effect of the study drug compared to placebo on calorie intake, energy metabolism, and appetite. The study will last up to 6 months and may include up to 20 visits.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 74
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• BMI greater than 30 kg/m2

• History of at least 1 self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria:

• Change in body weight of greater than 5 kg (11 pounds) within 3 months prior to start of study

• Any of the following treatments for obesity within 1 year prior, or plan to undergo any of these during the study period: liposuction, cryolipolysis, or abdominoplasty

• Prior or planned bariatric or gastric sleeve surgery, endoscopic therapy, or device-based therapy for obesity

• Type 1 or Type 2 Diabetes, history of ketoacidosis, or hyperosmolar state

• Family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome Type 2

• Acute or chronic hepatitis

• Had within 90 days prior: acute myocardial infarction, cerebrovascular accident (stroke), coronary artery revascularization, hospitalization for unstable angina, or hospitalization due to congestive heart failure

• History of active or unstable major depressive disorder or other severe psychiatric disorder within 2 years prior

• History of chronic or acute pancreatitis

• Blood transfusion or severe blood loss within the last 3 months or hemoglobinopathy, hemolytic anemia, sickle cell anemia

• Clinically significant multiple or severe drug allergies

• Started treatment with or changed dose within 12 months prior any medications that are associated with significant weight gain

• History of substance use disorder

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• LY3437943
Administered SC

Other:
• Placebo
Administered SC

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	AdventHealth Orlando	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in Total Calorie Intake at Lunch and Dinner (Combined)		Baseline up to Week 17 (inclusive)
Secondary	Change from Baseline in Sleep Metabolic Rate (SMR)	In participants who achieve target weight loss	Baseline up to Week 16 (inclusive)
Secondary	Change from Baseline in SMR		Baseline up to Week 16 (inclusive)
Secondary	Change from Baseline in 24-hour Energy Expenditure (EE)	In participants who achieve target weight loss	Baseline up to Week 16 (inclusive)
Secondary	Change from Baseline in 24-hour EE		Baseline up to Week 16 (inclusive)
Secondary	Change from Baseline in Total Calorie Intake at Lunch		Baseline up to Week 17 (inclusive)
Secondary	Change from Baseline in Total Calorie Intake at Dinner		Baseline up to Week 17 (inclusive)
Secondary	Change from Baseline in Fasting Appetite Visual Analog Score (VAS)		Baseline up to Week 16 (inclusive)

External Links

•   A Study to Measure Calorie Consumption and Usage in Participants With Obesity Using LY3437943